RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Explains Reasons for Refusing to Approve Another Oxycodone Drug

The US Food and Drug Administration (FDA) on Monday offered an explanation for refusing to approve Pharmaceutical Manufacturing Research Services, Inc.’s (PMRS) new drug application (NDA) for its oxycodone hydrochloride (HCl) immediate-release (IR) oral capsules.

The notice, published in Monday’s Federal Register, offers PMRS an opportunity to request a hearing on the matter and follows the agency’s decision to reject a citizen petition filed by the Pennsylvania-based company in May 2017 to stay the approval of Insipirion’s recently approved opioid RoxyBond (oxycodone hydrochloride).

On 31 October 2017, PMRS filed an action for declaratory and injunctive relief against FDA in the US District Court of Eastern Pennsylvania, claiming the agency had failed to respond to certain relevant arguments.

Among other charges, PMRS said FDA offered no response to its position that FDA relied on human abuse potential studies in approving RoxyBond, which PMRS said are “inherently flawed.” PMRS also filed a complaint in the same court in August. And since February 2016, PMRS has filed fourt citizen petitions with FDA.

FDA’s CRL and Explanation

FDA explained the CRL it sent to PMRS in November 2017, offering a few reasons for why the opioid is not abuse-deterrent, including because “the data submitted were not sufficient to rule out the possibility that the proposed formulation could result in a greater proportion of abuse by injection of PMRS’s product compared to a conventional IR oxycodone formulation.”

The agency also said PMRS has not provided sufficient data to show that the product would be safe and has not shown that “the methods used in, and the facilities and controls used for the manufacture, processing, or packing of the product are adequate to preserve its identity, strength, quality, and purity.”